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RIBASPHERE Medical Research Studies

Up-to-date List of RIBASPHERE Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest RIBASPHERE Medical Research Studies

Rank Status Study
1 Unknown  Ribavirin Pre-treatment Followed by Combined Standard Therapy in Hepatitis C Virus (HCV) Recipients
Condition: Hepatitis C
Intervention: Drug: ribavirin pre-treatment
Outcome Measures: HCV-RNA level, Transaminases level;   liver biopsy and Transient elastography at baseline and after six month since therapy conclusion
2 Recruiting Tailored Regimens of PEGASYS® and Ribavirin for Genotype 1 Chronic Hepatitis C Patients Trial (TARGET-1)
Condition: Hepatitis C
Interventions: Drug: A: Peg-interferon alpha-2a & Ribavirin;   Drug: B: Peg-interferon alpha-2a & Ribavirin;   Drug: C: Peg-interferon alpha-2a & Ribavirin;   Drug: D: Peg-interferon alpha-2a & Ribavirin;   Drug: E: Peg-interferon alpha-2a & Ribavirin;   Drug: F: Peg-interferon alpha-2a & Ribavirin
Outcome Measures: Efficacy;   Safety
3 Recruiting In Hepatitis C Patients Treated With Interferon and Ribavirin, Does Hepcidin Contribute to Treatment Induced Anaemia
Condition: Hepatitis C
Interventions: Drug: Pegylated interferon alpha;   Drug: Ribavirin
Outcome Measures: Hepcidin levels;   iron metabolism markers;   heamolysis markers;   inosine triphosphatase genetic variants;   erythropoiesis markers
4 Unknown  RIBAJUSTE Clinical Trial Investigating the Efficacy and Safety of Dose Adaptation of Ribavirin
Condition: Chronic Hepatitis C
Interventions: Drug: Peg-interferon alpha 2a and ribavin;   Drug: ribavirin with adaptation dose
Outcome Measures: Inter-group comparison of sustained virological response rates as defined by the proportion of subjects with a negative PCR HCV-RNA test at Week 72;   Efficacy endpoints;   safety endpoints;   Economic endpoints
5 Recruiting Induction Chemotherapy With Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)
Conditions: Head and Neck Cancer;   Squamous Cell Cancer
Intervention: Drug: Afatinib, Ribavirin, and weekly carboplatin/paclitaxel
Outcome Measures: maximum tolerated dose (For Dose Escalation Portion of the study);   expression of PTPN13 (For Expansion Cohort only);   safety and tolerability (toxicity);   objective response rate;   pharmacokinetics
6 Recruiting Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)
Condition: Hepatitis C Virus Genotype 4 Infection
Interventions: Drug: Asunaprevir;   Drug: Daclatasvir;   Drug: Ribavirin;   Drug: Pegylated Interferon alpha-2a
Outcome Measures: SVR12 Rate;   Number of patients with adverse events;   Treatment discontinuations;   Self-reported symptoms;   Patients' adherence;   SVR 24 rate;   HCV viral load;   Number of patients with virological failure under treatment;   HCV subtypic distribution;   Proportion of patients with resistance mutations to Asunaprevir and/or Daclatasvir in case of virological failure;   Cirrhosis evaluation;   Insulin resistance : HOMA-IR score;   Metabolic syndrome parameters;   Liver fibrosis;   Polymorphism of the gene of IL28B
7 Recruiting Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Condition: Hepatitis C
Interventions: Biological: Pegylated Interferon Lambda;   Drug: Ribasphere;   Drug: Daclatasvir
Outcome Measures: Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected;   Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected;   Proportion of non-cirrhotic HCV GT-1b subjects with treatment-emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3, and/or thrombocytopenia as defined by platelets < 50,000 mm3) on treatment;   Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated flu-like symptoms (pyrexia or chills or pain);   Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated musculoskeletal symptoms (arthralgia or myalgia or back pain);   Proportion of non-cirrhotic HCV GT-1b subjects with SVR24, defined as HCV RNA < LLOQ target detected or not detected;   Frequency of deaths among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks);   Frequency of Serious adverse events (SAEs) among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks);   Frequency of drug related Adverse events (AEs) among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks);   Frequency of dose reductions and discontinuations due to AEs among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks);   Frequency of treatment emergent laboratory abnormalities among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks);   Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated constitutional symptoms (fatigue or asthenia) through the end of treatment (maximum of 12 weeks);   Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated neurologic symptoms (headache or dizziness) through the end of treatment (maximum of 12 weeks);   Proportion of non-cirrhotic HCV GT-1b subjects with psychiatric symptoms (depression or irritability or insomnia) through the end of treatment (maximum of 12 weeks)
8 Recruiting Boceprevir/PegIFN α-2b/Riba in HCV+ Gt1 Menopausal Women, Nonresponders to PegIFN/Riba or Treatment-naives (MEN_BOC)
Conditions: Chronic Hepatitis C;   Menopause
Intervention: Drug: Pegylated Interferon, Ribavirin, Boceprevir
Outcome Measures: Improvement of sustained virological response in previous treatment failure or naive HCV-positive menopausal women.;   Early virological response
9 Recruiting Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C, Chronic
Interventions: Drug: Miravirsen;   Drug: Telaprevir;   Drug: Ribavirin
Outcome Measures: The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.;   The proportion of subjects with undetectable HCV RNA levels at end of treatment.;   The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.;   Change in HCV RNA levels from baseline throughout the study.;   The proportion of subjects who experience virological failure throughout the study.
10 Not yet recruiting A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
Conditions: Chronic Hepatitis C;   End Stage Renal Disease
Interventions: Drug: Ribavirin;   Drug: Peginterferon;   Drug: Boceprevir
Outcome Measures: Percentage of patients who achieve eRVR at treatment week 28;   Tolerability of treatment
11 Recruiting Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection
Condition: Hepatitis C Virus
Intervention: Drug: ribavirin
Outcome Measures: ribavirin AUC-12 variability;   safety - absolute hemoglobin declines;   efficacy - early and sustained virologic response
12 Unknown  Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment
Condition: Hepatitis C
Interventions: Other: Ribavrin;   Drug: Abacavir plus Ribavirin
Outcome Measures: To evaluate the effect of abacavir (ABC) on Ribavirin Triphosphate (RBV-TP) intracellular concentrations.;   To evaluate the effect of ABC on plasma RBV trough concentrations.
13 Unknown  Four Arms, Multicenter Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C
Condition: Chronic Hepatitis C
Interventions: Drug: pegylated interferon alpha 2a and plus ribavirin;   Drug: Pegylated interferon alfa-2a and ribavirin;   Drug: pegylated interferon alpha 2a and ribavirin
Outcome Measures: Efficacy - Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period;   Safety - adverse event rate and profile
14 Recruiting A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With and Without GSK23336805 With a Pharmacokinetic Enhancer With and Without Ribavirin in Patients Infected With Chronic Genotype 1 Hepatitis C Virus
Condition: Chronic Hepatitis C
Interventions: Drug: TMC647055;   Drug: TMC435;   Drug: Ritonavir;   Drug: Ribavirin;   Drug: Pegylated interferon alpha-2a (PegIFN);   Drug: GSK2336805
Outcome Measures: Number of patients with a sustained virologic response (SVR) 12 Weeks after the actual end of treatment;   Number of patients with adverse events;   Number of patients with a sustained virological response (SVR at 4 and/or 24 Weeks after the actual end of treatment);   HCV RNA levels over time;   Number of patients with undetectable hepatitis C virus (HCV) RNA (less than 25 IU/mL undetectable) and/or HCV RNA levels less than 25 IU/mL at all time points;   Number of patients with on-treatment virologic failure;   Number of patients with viral relapse;   Number of patients with presence of HCV variants associated with reduced susceptibility to investigational treatment;   Maximum plasma analyte concentration of TMC435;   Minimum plasma analyte concentration of TMC435;   Area under the plasma concentration-time curve of TMC435;   Maximum plasma analyte concentration of TMC647055;   Minimum plasma analyte concentration of TMC647055;   Area under the plasma concentration-time curve of TMC647055;   Maximum plasma analyte concentration of ritonavir (RTV);   Minimum plasma analyte concentration of RTV;   Area under the plasma concentration-time curve of RTV;   Minimum and maximum plasma concentrations of GSK233680k;   Area under the plasma concentration-time curve of GSK233680k
15 Unknown  Peginterferon Plus Ribavirin for Hepatitis C Patients Concomitant With Malignancy Other Than Hepatocellular Carcinoma
Conditions: Chronic Hepatitis C;   Neoplasms
Intervention: Drug: pegylated interferon alpha 2a and plus ribavirin
Outcome Measures: Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.;   Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4.;   Early virological response (EVR), by PCR-negative or at least 2 logs decline from baseline of serum HCV RNA at 12 weeks of treatment.;   Safety - adverse event rate and profile
16 Unknown  Phase I/II Study of Ribavirin Given as Monotherapy in Solid Tumour Cancer Patients
Condition: Malignant Solid Tumour
Intervention: Drug: Ribavirin
Outcome Measures: Phase I: Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D);   Phase II: Determine the overall response rate to therapy with ribavirin;   Incidence and nature of DLTs;   Incidence, nature and severity of adverse events;   Time to and duration of response, defined as the first occurence of documented objective response until the time of recurrence or death from any cause;   Clinical benefit rate, defined as the overall response rate and stable disease for greater than or equal to 24 weeks;   Pharmacokinetic parameters of ribavirin determine by total exposure, maximum plasma concentration, etc.;   Correlation between eIF4E activity and response;   To determine the effect of ribavirin on the activity of eIF4E related pathways through correlative studies
17 Unknown  Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?
Condition: Chronic Hepatitis C
Interventions: Drug: Peg + Vitamin D + Ribavirin;   Drug: Peg + Ribavirin
Outcome Measure: sustained virologic response (SVR)rate
18 Recruiting An Open Label Trial of Pegylated Interferon, Ribavirin and Telaprevir Versus Pegylated Interferon and Ribavirin Alone in the Treatment of Hepatitis C Genotype 1 Virus Infection in Patients With HIV-1 Co-infection
Condition: HIV
Interventions: Drug: Ribavirin;   Drug: Telaprevir
Outcome Measure: • Comparison of rates of sustained virologic response(SVR24) between treatment arms; defined as HCV RNA not detectable at 24 weeks after planned completion of therapy
19 Unknown  Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies
Condition: Hemoglobinopathies
Intervention: Drug: PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin
Outcome Measures: A sustained virological response (SVR), defined as absence of HCV RNA in serum by a highly sensitive test at the end of treatment and 6 months late.;   Early virological response (EVR) , defined as the loss of HCV RNA during the first 12 weeks of therapy; main side effects enclosing changes in blood transfusion requirement; increase in ferritin levels and variations in chelation treatment
20 Unknown  Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients
Condition: Chronic Hepatitis C
Interventions: Drug: ribavirin;   Drug: Peginterferon alfa-2a;   Drug: epoetin beta
Outcome Measure: % patients with RNA-HCV < 50 UI/ml

These studies may lead to new treatments and are adding insight into RIBASPHERE etiology and treatment.

A major focus of RIBASPHERE research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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